Client:

Medlogics Device Corporation, founded in 2004, is a biotech startup focused on the
development of an effusive stent. The founder of the company left his position as
President of an established biotech firm, Bioheart. Medlogics is backed by strong VC
funding and is testing its stent internationally.

Challenges:

The client is a startup and has limited resources to devote to the clinical study process.
The personnel in the company are best suited to product development, design testing,
clinical monitoring and interpreting results; not setting up and running the clinical study,
particularly from a data collection standpoint.

How we helped based on specifications created by client:

-Configured Clinical Data Management System (Oracle Clinical)
-Managed the clinical data collection, data entry, and validation process

Specification:

-Designed and implemented the data management plan and edit check
-Implemented CDMS verification logic for study data entry
-Enabled the Medlogics R&D team to focus its limited resources on high value
-Allowed the Medlogics management to focus its energies on running the company
-Added activities in the refinement of the product
-Not on clinical trial management